Postoperative Analgesia in Abdominal Surgery: a Medico-economic Study

Abdomino-perineal Amputation Under Laparotomy Clinical Trial

— PERIDIGE  

Official title:

Epidural Analgesia vs. Morphine Patient-controlled Analgesia in Abdominal Surgery Under Laparotomy : a Medico-economic Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01470846
• Other study ID #: I10030 PERIDIGE
• Status: Terminated
• Phase: Phase 4
• First received: November 8, 2011
• Last updated: August 13, 2014
• Start date: November 2011
• Est. completion date: April 2013

Study information

• Verified date: August 2014
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Background : Epidural anaesthesia is associated in abdominal surgery with reduced pain and postoperative respiratory complications together with quicker recovery of bowel function. Currently, no studies have been able to prove its ability to reduce length of stay in intensive care and high-dependency units.

Purpose : The aim of this study is to demonstrate that epidural anaesthesia reduces length of stay in intensive care unit after abdominal surgery under laparotomy.

Description:

There are currently two methods of analgesia in postoperative abdominal surgery :

patient-controlled analgesia (PCA) with opioids and epidural analgesia.

No international recommendations regarding the use of either of these techniques have yet been written. Epidural analgesia is superior to intravenous morphine, including during mobilization and coughing. It also reduces respiratory complications and optimizes postoperative rehabilitation. Nevertheless, mortality is not improved with this technique. Few publications exist on the optimization of the duration of hospitalization in the intensive care unit.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Surgery scheduled under laparotomy

• Extended ileal resection

• Total proctocolectomy

• Colectomy left/right/total

• Rectosigmoidal resection

• Anterior resection of rectum

• Abdomino-perineal amputation

• Adult patient

• Written consent obtained

• Planned hospitalization in the intensive care unit

• Patient affiliated to social security

Exclusion Criteria:

• Patients inapt to give consent

• Emergency surgery

• Contraindication to epidural analgesia

• Contraindication to levobupivacaïne, morphine or sufentanil

• Dementia

• Participation in another research protocol

• Pregnancy or breastfeeding

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdomino-perineal Amputation Under Laparotomy
• Anterior Resection of Rectum Under Laparotomy
• Colectomy Left/Right/Total Under Laparotomy
• Extended Ileal Resection Under Laparotomy
• Rectosigmoidal Resection Under Laparotomy
• Total Proctocolectomy Under Laparotomy

Intervention

Procedure:
• epidural analgesia
thoracic position (T8-T9 or T11-T12) depending on the site of surgery
• PCA
Morphine 2 mg / 10 min (no max dose) + droperidol 2.5 mg / 50 mL.

Locations

Country	Name	City	State
France	CHU de Limoges - Service d'anesthésie-réanimation	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Theoretical duration of hospitalization in intensive care unit.	The difference between the day of surgery and the day when discharge criteria for intensive care unit are met.	5 days	No
Secondary	Total duration of hospitalization.	The difference between the day of surgery and the day when the discharge criteria are met	9 days	No